Kornimate/medical-research-clean huggingface dataset:
a study of dalcetrapib in patients with stable coronary heart disease, with coronary heart disease risk equivalents or at elevated risk for cardiovascular disease

Conditions: Cardiovascular Disease, Coronary Heart Disease, Dyslipidemia, Peripheral Arterial Disease (PAD)

Summary: this multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (chd), with chd risk equivalents or at elevated risk for cardiovascular disease. eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. anticipated time on study treatment is 4 years.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 45 years of age * established cardiovascular disease a stable coronary disease b cerebrovascular disease c peripheral artery disease * without established coronary disease d pharmacologically treated type 2 diabetes mellitus and one or more risk factor(s) for cardiovascular disease e 3 or more risk factors for cardiovascular disease * receiving evidence-based medical and dietary management of dyslipidemia exclusion criteria: * occurrence of myocardial infarction, hospitalization for unstable angina, stroke or revascularization (coronary, carotid or peripheral) within three months prior to randomization * uncontrolled hypertension * uncontrolled diabetes * concomitant treatment with any other drug raising hdl-c * previous treatment with compounds targeting cholesteryl ester transfer protein (cetp)
a canadian study of persistence on ofatumumab using patient support program data

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this was an observational, non-interventional, real world study involving secondary use of de-identified aggregate data from patients prescribed ofatumumab, collected by the kesimpta go program in canada. this study utilized a cohort design. the study period included all available data captured by the kesimpta go program from program inception (april 2, 2021) to the time of data transfer (may 1, 2024). patients were indexed into the study on the date they started their medication, from april 2, 2021 to may 1, 2024. the baseline period represented the period prior to ofatumumab treatment initiation. baseline variables were collected from the enrollment form, which include demographic and clinical history, such as whether the patient had prior treatment with disease-modifying therapy (dmt). patients were followed until the first of the following censoring events: ofatumumab discontinuation; end of the study period; or leaving the kesimpta go program.


Eligibility criteria:
inclusion criteria: patients were included if they met all of the following criteria: * patients enrolled in the kesimpta go program * patients with documented informed consent from enrollment in the kesimpta go program * patients who started treatment with ofatumumab exclusion criteria: patients were excluded if they met any of the criteria below: * patients with no demographic information * patients who could not be linked across the data sources required for analysis (kesimpta go program enrollment form, pharmacy claims forms, kesimpta go program database) * patients with 3+ treatment interruptions (patient was "on hold" - i.e., not currently receiving the treatment in the patient support program)

Keywords: patient support program ofatumumab persistence
pca administration in prosthetic joint infection

Conditions: Prosthetic Joint Infection

Summary: determine if dietary protocatechuic acid (pca) will affect health biomarkers in patient undergoing revision surgery for a knee prosthetic joint infection

patients who are scheduled to undergo revision surgery for a knee prosthetic joint infection are given pca prior to surgery for a time period determined by a previous pilot study. pca is then post-operatively until anticoagulation is stopped, and then will be resumed for four years post revision surgery. measurement of changes in glucose control, immunity, will be measured over the first 3 months post-revision, and the post-revision reinfection rate over the full 4 years will be compared to a cohort rate

Eligibility criteria:
inclusion criteria: * 3 weeks or more after total knee arthroplasty * one or more symptoms of infection, including redness, swelling, pain, increasing range of motion loss, fever, nausea, and loss of appetite. * wbc count of aspirate \>50,000 cells per μl exclusion criteria: * not willing to undergo blood draw at 3 months.
a trial to learn if the combination of fianlimab, cemiplimab, and chemotherapy is safe and works better than the combination of cemiplimab and chemotherapy in adult patients with non-small cell lung cancer that can be treated with surgery

Conditions: Resectable Non-small Cell Lung Cancer

Summary: this study is researching an experimental drug called fianlimab (also called regn3767) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. the study is being conducted in patients who have resectable stage ii to iiib (n2) non-small cell lung cancer (nsclc) that can be treated with surgery. the aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with nsclc. the study is looking at several other research questions, including: * what side effects may happen from taking the study drugs * how much of each study drug is in the blood at different times * whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) * how administering the study drugs might affect quality of life


Eligibility criteria:
key inclusion criteria: 1. patients with newly diagnosed, histologically confirmed, fully resectable stage ii to iiib (n2) nsclc as per american joint committee on cancer (ajcc) version 8 2. for patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol 3. all patients must have disease status showing no evidence of distant metastases documented by a complete physical examination and imaging studies performed within 4 weeks prior to randomization as defined in the protocol 4. a patient must have an evaluable programmed cell death ligand-1 (pd-l1) immunohistochemistry (ihc) result as defined in the protocol 5. eastern cooperative oncology group (ecog) performance status of 0 or 1 6. adequate bone marrow, hepatic and kidney function as defined in the protocol key exclusion criteria: 1. any evidence of locally advanced unresectable or metastatic disease as defined in the protocol 2. patients with tumors with known epidermal growth factor receptor (egfr) gene mutations, anaplastic lymphoma kinase (alk) gene translocations as defined in the protocol 3. uncontrolled infection with human immunodeficiency virus (hiv), hepatitis b (hbv) or hepatitis c virus (hcv) infection as defined in the protocol 4. treatment with anti-cancer therapy including immunotherapy, chemotherapy, radiotherapy, or biological therapy in the 3 years prior to randomization. adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed. 5. patients with a history of myocarditis note: other protocol-defined inclusion/ exclusion criteria apply

Keywords: stage ii to iiib (n2) nsclc neoadjuvant therapy subsequent adjuvant therapy perioperative
genetic information as a life style change motivator

Conditions: Health Behavior; Alzheimer Disease, Protection Against

Summary: the study investigates whether information on having a risk genotype (apoe4) and life style advisory information affects lifestyle changes and sensory preferences. the project studies also the ethic aspects of giving the information of risk genotype.

we will run intervention based on our earlier pilot study. it includes intensive intervention and a modification of our earlier pilot intervention. our intervention methods are general lectures of the effects of healthy diet (finnish nutrition recommendations 2014) and healthy lifestyle for all participants. effects on motivation, attitudes and preferences will be studied and verified by questionnaires and risk factors of cardiovascular disease and alzheimer disease by analyzing clinical markers of lipid metabolism, general phenotype markers and profiles of nutritional markers. nutritional biomarkers will verify also the self-reported changes of diet in the questionnaires and in digital food diaries.

Eligibility criteria:
inclusion criteria: * age between 40 and 60 years * overall good health (no chronic conditions e.g. mental disorders, cancer, liver or kidney disease, current or previous diagnosis), * body mass index (bmi) under 35 kg/m2, * blood pressure under 140/90 mmhg (medication allowed), * serum total cholesterol under 7.25 mmol/l (medication allowed) * fasting plasma glucose level under 7 mmol/l. exclusion criteria: * abnormal values of the alanine amino transferase, alkaline phosphatase, haptoglobin and thyroid stimulating hormone
a pilot study of prophylactic management of lamotrigine in pregnant women

Conditions: Bipolar Disorder; Major Depressive Disorder; Schizo Affective Disorder

Summary: pregnant women who are taking lamotrigine will be evaluated monthly during pregnancy including a clinical evaluation and a blood draw for lamotrigine levels at each visit. based on the therapeutic drug monitoring protocol, participant's lamotrigine dosing will be adjusted as needed based on participant's blood levels compared to the reference concentration that was obtained prior to pregnancy or early in pregnancy while clinically stable. after delivery participant and participant's infants will be assessed for mood and functioning at 1, 2, 4, and 6 weeks postpartum.

studies have demonstrated that at least 80% of women who stop mood stabilizing medications for pregnancy relapse psychiatrically. however, relapse is also quite common in women who continue taking mood stabilizing medication with studies demonstrating approximately a 30-37% relapse rate-most with depressive episodes. one likely explanation for the high relapse rate of bipolar disorder during pregnancy despite continued mood stabilizing medication is decreasing blood levels of mood stabilizing medications during the course of pregnancy. pregnancy induces both pharmacokinetic and pharmacodynamic changes, which can result in decreased serum blood levels and decreased treatment efficacy. therapeutic drug monitoring is considered standard of care for a number of psychiatric medications. therapeutic drug monitoring can be an especially crucial guide to clinical treatment during pregnancy, but remarkably, there are no established protocols for the monitoring of levels and dosing of psychiatric medications in pregnancy. most pregnant psychiatric patients are therefore managed based on symptom recurrence. in contrast, there are established protocols for monitoring blood levels and prophylactic management of antiepileptic medications for epilepsy, including lamotrigine which is also a mood stabilizing medication. the investigators will collect pilot data on the psychiatric outcomes, adverse events, and obstetrical and infant outcomes of pregnant women with bipolar disorder who undergo prophylactic therapeutic drug monitoring for a commonly used mood stabilizing medication during pregnancy- lamotrigine. in the epilepsy literature, there is a published protocol for lamotrigine management before, during, and after pregnancy for seizure control; the investigators will use this protocol as a guide.

Eligibility criteria:
inclusion criteria: * pregnant, prior or 20 weeks * currently taking lamotrigine and plan to continue throughout pregnancy * history of bipolar disorder, major depressive disorder, schizoaffective disorder or other psychiatric illness, currently stable * may be taking other psychiatric medications exclusion criteria: * suicidal/clinically unstable * alcohol, marijuana, or other drug dependence in last 90 days

Keywords: lamotrigine bipolar disorder major depressive disorder schizo affective disorder
identification of cytokine profiles and t cell subsets among immunosuppressed patients at risk of developing active tuberculosis

Conditions: Tuberculosis; HIV Infections; Rheumatoid Arthritis

Summary: the purpose of this study is to identify differences in tb specific immune responses among immunosuppressed patients latently infected with tb and patients with active tb.

immunosuppressed patients latently infected with tb are at higher risk of developing active tb than patients with normal immune functions. especially two patient categories are at risk: hiv positives and patients receiving tnf-a blocking medication. existing methods of diagnosis and surveillance of latent tb infection can not identify who will develop active tb and who can control the infection. there is a need for better understanding of tb specific immune functions,as we believe deficient tb specific immune reactions is a key in reactivation of latent tb infection. in this study we follow groups of latent tb infected patients with either rheumatoid arthritis or hiv. we follow the patients during treatment with tnf-a blocking medication, haart treatment or prophylactic tb medication. results are correlated to patients with active tb, latent tb and healthy controls.

Eligibility criteria:
inclusion criteria: * latent tb infection + rheumatid arthritis * latent tb infection + hiv * active tb exclusion criteria: * age \< 18yrs * pregnancy * patients not able to understand the given information

Keywords: hiv
endovenous radiofrequency ablation closure system in the treatment of varicose veins

Conditions: Varicose Veins

Summary: the goal of this clinical trial is to evaluate the effectiveness and safety of the endovenous radiofrequency ablation closure system produced by suzhou hengrui hongyuan medical technology co., ltd. for the treatment of varicose veins.

in this prospective, multi-center, randomized controlled study, 176 patients who were diagnosed with varicose veins and met the inclusion criteria without any exclusion criteria were randomly divided into the experimental group (hongyuan endovenous radiofrequency ablation closure system)and control group (medtronic's closurefast™ radiofrequency ablation system) at 1:1. the effectiveness of the product was evaluated by the vascular closure rate at 6 months after the operation, and the safety of the product was evaluated by the incidence of adverse events and serious adverse events within 6 months after the operation.

Eligibility criteria:
inclusion criteria: 1. age 18-80 years old, no gender limit. 2. great saphenous varicose, ceap grade c2-c6. 3. the diameter of the diseased vein is ≥2mm, ≤15mm. 4. expected survival period ≥ 6 months. 5. the informed consent form can be signed by the patient or the legal representative. exclusion criteria: 1. are pregnant or breastfeeding. 2. participating in clinical trials of other devices or drugs. 3. deep vein thrombosis in the affected limb. 4. uncorrectable coagulation dysfunction and obvious abnormal blood picture, with obvious bleeding tendency (platelets≤30x109/l). 5. acute thrombosis in the main saphenous vein of the affected limb. 6. the investigator judged that it is not suitable to participate in the clinical trial.
ultrasonic measurement of ivc and ijv in predicting hypotension after anesthesia induction

Conditions: Anesthesia

Summary: this research is expected to study ultrasonic measurement of internal jugular vein and inferior vena cava, which can be used as a good index to predict hypotension after anesthesia induction, and its measurement method is simple and quick.

the induction of anesthesia is the process from the physiological state to the anesthetic state in a short period of time. hypotension after anesthesia induction is closely related to many organ injuries. gastrointestinal surgery patients' prohibition of fasting is an important mechanism of severe hypotension after anesthesia induction. at present, ultrasonic measurement of inferior vena cava and internal jugular vein has been proved to be a convenient and non-invasive means to evaluate patients' blood volume. the purpose of this research was to study the relativity between ultrasonic measurement of inferior vena cava and internal jugular vein and hypotension after anesthesia induction in patients.

Eligibility criteria:
inclusion criteria: * gastrointestinal surgery * bmi 18\~24 * asa score gradeⅰ\~ iii exclusion criteria: * anemia * cirrhosis * emergency surgery * severe hypertension * new york heart association iii \~ iv or ejection fraction \<40% * cirrhosis * other serious systemic diseases
intravitreal aflibercept for macular edema due to central retinal vein occlusion

Conditions: Retinal Vein Occlusion; Vascular Occlusive Disease

Summary: central retinal vein occlusion (crvo) is a common retinal vascular disorder, occurring when there is a blockage to the main blood vessel that transports blood away from the retina. crvo may cause visual impairment, especially due to macular edema (swelling of the macula due to fluid accumulation) and macular non-perfusion. aflibercept has been found to improve visual acuity and reduce macular thickness in pivotal trials. the purpose of this study was to evaluate the efficacy and safety of intravitreal aflibercept in real-world, using a patient-fitted treatment regimen. additionally, imaging parameters have been assessed before and after treatment with intravitreal aflibercept.


Eligibility criteria:
inclusion criteria: * treatment naive center-involved macular edema secondary to crvo for no longer than 3 months. * patients \>18 years of age, who are diagnosed with macular edema secondary to crvo who are scheduled to be treated with intravitreal aflibercept in real-life conditions * bcva of snellen of 20/40 to 20/200 in the study eye exclusion criteria: * previous prp or macular laser photocoagulation in the study eye. * any prior ocular treatment in the study eye for macular edema secondary to crvo. * prior systemic anti-vegf or corticosteroid therapy, within the last 3 months before enrollment to the study. * any active or previous inflammation, ocular trauma * uncontrolled glaucoma (iop\>30 mmhg)

Keywords: optical coherence tomography angiography aflibercept retinal vein occlusion biomarkers
saxagliptin treatment in subjects with type 2 diabetes who are not controlled with diet and exercise

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this clinical research study is to learn whether saxagliptin (bms-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

all subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. subjects who complete the short-term period will be eligible to enter the long term extension period. also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin added onto their blinded study medication. subjects with screening hemoglobin a1c (a1c) \> 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into open-label treatment cohort (direct enrollees) and receive open-label saxagliptin 10 mg. those who completed the short-term period were eligible to enter into the long-term treatment extension period.saxagliptin dose titration was not permitted.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * drug naive * hemoglobin (hb) a1c \>= 7.0% and \ 10% and \<= 12% for open label arm) * fasting c-peptide \>= 1 ng/ml * body mass index \<= 40 kg/m2 exclusion criteria: * symptomatic poorly controlled diabetes * recent cardiac or cerebrovascular event * serum creatinine \>= 1.5 mg/dl for males and \>= 1.4 mg/dl for women of child bearing potential
aspiration treatment of perianal abscess

Conditions: Anal Fistulas

Summary: the purpose of this study is to compare aspiration and oral antibiotics with surgical incision in the treatment of perianal abscesses in terms of recurrence and subsequent fistula formation. included patients will be randomised to either aspiration or incision.

anorectal abscess is a common condition, caused by cryptoglandular polymicrobial infection, where the traditional treatment is surgical drainage. anorectal abscess is associated with recurrence rates between 6-44 % after surgical drainage and persistent subsequent fistula up to 37 %. inadequate incision, missed abscess components or fistulas can be the cause of recurrence . surgical drainage is associated with discomfort from prolonged wound healing, affecting the daily activities as well as the potential risk of complicated scaring and fecal incontinence. less invasive method with pus aspiration under antibiotic cover has been shown to be safe in terms of recurrence rate and subsequent fistula formation and well tolerated by the patients with less morbidity and wound complications and a potential lower risk of fecal incontinence. however, this has been shown only in few studies with small population and no randomized controlled study comparing the two approaches has been conducted or published to our knowledge. the risk factors of recurrence and subsequent fistula formation are not that clear but age below 40 years, absence of diabetes mellitus and recent smoking are shown to be risk factors for developing recurrent abscess and fistula. applying aspiration and antibiotics method for the treatment of perianal abscess can be an advantage for the society due to a shorter recovering period, quicker return to daily activity and work and avoiding wound healing problems and sphincter damage; thus lower expenses. the results of this study have the potentials to reveal the risk factors of developing fistula after perianal abscess.

Eligibility criteria:
inclusion criteria: 1. ≥18 yrs old 2. perianal abscess (without spontaneous rupture) 3. abscess larger than 2 cm in diameter 4. signed informed consent exclusion criteria: 1. malignancy within 5 yrs 2. previous radiotherapy of the abdomen and pelvis 3. recurrent abscess within 6 months 4. immune suppressed patients 5. pregnant and lactating women 6. abscess with horseshoe formation 7. allergy to clindamycin